Events

Recall of Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline 2, Procalcitonin, Folate, DHEA-SO4, CA 19-9, BR Assay for CA 15-3, BR Assay for CA 27.29, BNP (B-type Natriuretic Peptide), In vitro diagnostic medical devices (IVDs)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2012-RN-01135-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01135-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The operating range of the advia centaur systems is 18°c to 30°c. the affected assays can product inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.This phenomenon is observed when assay results are reported at a temperature different from the temperature at which the assay was calibrated. depending on the frequency of quality control testing and laboratory temperature at the time quality controls are tested, this issue may not always be detected through routine quality control monitoring.
  • Action
    Customers are being advised to immediately implement the revised room temperature operating ranges for the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur CP assays

Device

Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline...
  • Model / Serial
    Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline 2, Procalcitonin, Folate, DHEA-SO4, CA 19-9, BR Assay for CA 15-3, BR Assay for CA 27.29, BNP (B-type Natriuretic Peptide), In vitro diagnostic medical devices (IVDs)Theophylline 2ARTG: 175699Procalcitonin, DHEA-SO4ARTG: 175698FolateARTG: 175700BR Assay for CA 15-3, CA 19-9, BR Assay for CA 27.29ARTG: 175636BNPARTG: 175075Multiple SN and REF Numbers
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA